Label: BISMUTH SUBSALICYLATE capsule, gelatin coated

  • NDC Code(s): 68210-4152-1
  • Packager: Spirit Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 11, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient ( in each softgel)                        Purpose

    Bismuth subsalicylate 262 mg ................Upset stomach reliever and anti-diarrheal

  • Uses

    relieves

    •  travelers' diarrhea 
    • diarrhea
    •  upset stomach due to overindulgence in food and drink, including: heartburn, indigestion,  nausea, gas, belching
    • fullness
  • Warnings

    Reye's syndrome:

     Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product.
    When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an
    early sign of Reye’s syndrome, a rare but serious illness.

    Allergy alert: Contains salicylate. Do not take if you are

    • allergic to salicylates (including aspirin)
    • taking other salicylate products

    Do not use if you have

    • an ulcer
    •  a bleeding problem
    • bloody or black stool

    Ask a doctor before use if you have

    •  fever 
    • mucus in the stool

    Ask a doctor or pharmacist before use if you are

    taking any drug for

    • anticoagulation (thinning the blood) 
    •  diabetes 
    • gout 
    • arthritis

    When using this product

    • a temporary, but harmless, darkening of the stool and/or tongue may occur

    Stop use and ask a doctor if

    • symptoms get worse or last more than 2 days
    • ringing in the ears or loss of hearing occurs
    • diarrhea lasts more than 2 days

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    •  swallow with water, do not chew
    •  adults and children 12 years and over:
    •  2 softgels every ½ hour or 4 softgels every hour as needed for
      diarrhea
    •  2 softgels every ½ hour to 1 hour as needed for overindulgence (upset
      stomach, heartburn, indigestion, nausea)
    •  do not exceed 8 doses (16 softgels) in 24 hours
    •  use until diarrhea stops but not more than 2 days
    •  children under 12 years: ask a doctor
    •  drink plenty of clear fluids to help prevent dehydration caused by
      diarrhea
  • Other information

    • each softgel contains: salicylate 102 mg
    • very low sodium
    •  do not exceed 25°C
  • Inactive ingredients

    aerosil, beeswax, FD&C Red#33, FD&C Yellow#6, gelatin, glycerin, light liquid paraffin, purified water, soya lecithin, sodium carboxy methyl cellulose, sorbitol solution, titanium dioxide

  • Questions or comments?

    1-888-333-9792

  • PRINCIPAL DISPLAY PANEL

    Stomach relief

    Bismuth Subsalicylate 262 mg
    Upset Stomach Reliever/Antidiarrheal

    Soothing relief for 5 symptoms:
    • Heartburn • Indigestion • Upset stomach
    • Nausea • Diarrhea

    12 Softgels

    image description

  • INGREDIENTS AND APPEARANCE
    BISMUTH SUBSALICYLATE 
    bismuth subsalicylate capsule, gelatin coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-4152
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE262 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVAL (Oblong shaped) Size21mm
    FlavorImprint Code 262
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-4152-11 in 1 CARTON04/29/2021
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00804/29/2021
    Labeler - Spirit Pharmaceuticals LLC (179621011)
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